Why PMCF under MDR feels harder than it reads (and what I actually do about it)

I’ve been writing PMCF plans and defending them to notified bodies for the better part of five years. On paper, PMCF under MDR is straightforward: Annex XIV sets out the requirement for ongoing clinical follow‑up after CE marking, and Annex II section 6.1 tells you to include clinical evidence in the Technical File. In practice, “ongoing” turns into multi-year commitments, and “evidence” turns into a negotiation with your notified body about what is acceptable and what isn’t. Below I share the r